Rutvik Gor, Ms Email & Phone Number

Minneapolis, Mn, Us

• Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA and other worldwide government agencies and write regulatory justifications to support submission filing decisions. • Compiling all materials required for submissions, license renewals and annual registrations such as PMA suppliments, MDR, UKCA.• Ensuring regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. • Interacting with regulatory authorities during the development and review process to ensure submission approval. • Recommending changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.• Review and approve product labeling and promotional materials, per company procedures, to assure compliance with regulatory requirements. • Maintaining current knowledge of the development and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals with the company. • Anticipating regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams

Princeton, New Jersey, Us

• Collaborated with other teams within Regulatory Affairs to Provide support in performing routine submission publishing activities associated with electronic and hard copy submissions• Worked closely with cross-functional team members and Submissions Team to compile documents needed for submission, manage version control, and track documents for assigned projects• Processed paper submissions for INDs, NDAs, BLAs, and ODAs per FDA/ICH guidelines and FDA's current thinking stated at conferences and submit to the Agency

North Andover, Ma, Us

Executed regulatory strategies and reports for CDSCO(India), PDMA(Japan), TGA(Australia), & EU MDR(Europe)• Outlined requirements of local advisory agencies or consultants of the respected country for the medical device approval process.• Compiled key submission requirements including device classification, regulatory pathways, registration methods, post-market surveillance of class II, III medical devices.• Delivered comparison of detailed regulatory submission requirements in different markets (EU, Japan, India, Australia)

Boston, Ma, Us

Boston, Ma, Us

Boston, Ma, Us

Princeton, New Jersey, Us

• Created an Ingredient Database, a regulatory tool containing the regulatory assessment of various cosmetic ingredients across the globe which will help in effective regulatory analysis.• Developed an Excel Sheet containing country-wise regulatory information on cosmetic ingredients extracted from Regulatory Health Authority websites.• Analysed and studied the identity, functions, regulatory status, limits, ranges, restrictions, prohibitions, CAS numbers, labeling, and safety considerations of these ingredients and presented this information in an Excel Sheet.

Master Of Science - Ms, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs

Bachelor'S In Pharmacy, Bachelors In Pharmacy